Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Impact of Thromboaspiration during Primary PCI on Microvascular Damage and Infarct Size: Acute and Long term

CE-MRI Evaluation.

MASSIMO MANCONE, MD; RAFFAELE SCARDALA, MD; CHIARA BUCCIARELLI DUCCI,MD;ANGELO DI ROMA,MD; IACOPO CARBONE,MD*;GIULIA BENEDETTIGIULIA CONTI,MD ; FRANCESCO FEDELE, MD.

GENNARO SARDELLA, MD, FACC ,FESC;

O.U. of Invasive Cardiology, Dept. of Cardiovascular Sciences*Dept.of Radiology

Policlinico Umberto I - University “La Sapienza ROME

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

No relationship to disclose

GENNARO SARDELLA,MD; MASSIMO MANCONE,MD; RAFFAELE SCARDALA, MD; CHIARA BUCCIARELLI DUCCI,MD; ANGELO DI ROMA,MD; IACOPO CARBONE,MD*; GIULIA BENEDETTI MD, GIULIA CONTI,MD; FRANCESCO FEDELE, MD.

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Myocardial Perfusion After Primary PCI is Strongest Predictor of Mortality independently from IRA reopening

8080

8585

9090

9595

33

22

0/10/1

100100

Cum

ulat

ive

Sur

viva

l (%

)

00 22 44 66 88 1010 12127575

Final Blush Score (patients with Final Blush Score (patients with final TIMI 3 flow)final TIMI 3 flow)

Blush 1-Year MortalityBlush 1-Year Mortality

3322

0/10/1

6.8%6.8%13.2%13.2%18.3%18.3%

PP=0.004=0.004

Stone GW, et al. Stone GW, et al. J Am Coll Cardiol.J Am Coll Cardiol. 2002;39:591-597. 2002;39:591-597.

Background

“ Open Artery ...but Closed Myocardium !!

PPCI Hardest point

( Courtesy of M.Gibson)

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

DesignDesign Prospective, randomized, double-arm, mono-centric

study.

Primary end-point : Final MBG ≥ 2 ; 90’ ST resolution (> 70% decrease of ST segment

after PCI)

Secondary end-point : MACE at 9 month clinical f-u

Principal investigator G.Sardella MD

Prospective, randomized, double-arm, mono-centric

study.

Primary end-point : Final MBG ≥ 2 ; 90’ ST resolution (> 70% decrease of ST segment

after PCI)

Secondary end-point : MACE at 9 month clinical f-u

Principal investigator G.Sardella MD

256 pts. (STEMI, at 6.8 ± 2.3 h from symptoms onset)

256 pts. (STEMI, at 6.8 ± 2.3 h from symptoms onset)

81 pts.excluded:Cardiogenic shock

3-vessel / Left Main

TIMI >0-1

TS < 3

Contra to GPIIb/IIIa

81 pts.excluded:Cardiogenic shock

3-vessel / Left Main

TIMI >0-1

TS < 3

Contra to GPIIb/IIIa

175 pts. eligible for 1:1 randomization

175 pts. eligible for 1:1 randomization

88 pts randomized to

Thrombectomy + PCI

88 pts randomized to

Thrombectomy + PCI

87 pts randomized to Standard PCI

87 pts randomized to Standard PCI

9 months clinical f-u 9 months clinical f-u

(Heparin 7.500 U/I, GPIIb/IIIa, Aspirin, Clopidogrel 300 mg)

Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI

( EXPIRA Trial ).

(G.Sardella et al presented at TCT 2007)

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Procedural Results MYOCARDIAL BLUSH GRADE

0

10

20

30

40

50

60

70

80

90

100

Basal Final Basal Post-Thr. Final

MBG 3

MBG 2

MBG 0/1

EXPORT GROUP CONVENTIONAL GROUP

%

*p=<0.0001

Post- POBA

Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI

( EXPIRA Trial ).

39.5*

11.8*

28.7*

70.3*

(G.Sardella et al ,TCT 2007)

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

90’ ST resolution after PCI (%)( > 70% decrease of ST segment)

EXPORT

GROUP

CONVENTIONAL

GROUP

Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI

( EXPIRA Trial ).

%

p=<0.01

80.0

0

10

20

30

40

50

60

70

80

90

100

37.5

OR 6.36 (95% CI 3.23-12.50)

(G.Sardella et al ,TCT 2007)

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

4,6

0

10,3

4,5

0

2

4

6

8

10

12

DEATH MACE

CONTR.

EXPORT

Pts %

p=0.059

p=ns

9 months Composite Cardiac Event Rates

Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI

( EXPIRA Trial ).

(G.Sardella et al ,TCT 2007)

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Aim of the Study

Export® aspiration catheter (Medtronic, Minneapolis, Minnesota)

We sought to evaluate the impact of thromboaspiration on procedural and long term outcomes in terms of microascular damage and infarct size by contrast enhanced-MRI (ce-MRI) as compared to conventional primary PCI.

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

DesignDesign Prospective, randomized, double-arm, mono-centric study.

End-points (MRI evaluation)

Microvascular damage (grams/g) in terms of Hypoenhancement .

Infarct size (grams/g) in terms of Hyperenhancement.

Prospective, randomized, double-arm, mono-centric study.

End-points (MRI evaluation)

Microvascular damage (grams/g) in terms of Hypoenhancement .

Infarct size (grams/g) in terms of Hyperenhancement.

Methods

75 patients eligible for 1:1 randomization(Anterior STEMI, at 6.8 + 2.3 h from symptoms

onset)

75 patients eligible for 1:1 randomization(Anterior STEMI, at 6.8 + 2.3 h from symptoms

onset)

38 pts randomized to

Thrombectomy + PCI

38 pts randomized to

Thrombectomy + PCI

37 pts randomized to Standard PCI

37 pts randomized to Standard PCI

3 – 90 Day MRI follow-up 3 – 90 Day MRI follow-up

Microvascular damageInfarct size Microvascular damageInfarct size

(Heparin 7.500 U/I, GPIIb/IIIa, Aspirin, Clopidogrel 300 mg)

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Inclusion Criteria Exclusion CriteriaMethods

Age >18 yrs

STEMI within 9 hrs from symptoms

onset

“De novo” coronary artery lesions

Native IRA ≥2.5 mm diameter

Angiographically identifiable occlusive

thrombus (TS grade ≥ 3)

TIMI 0-1 at time of initial angiography

Previous AMI or CABG

Cardiogenic shock

3-vessel / Left Main CAD

Severe valvular heart disease

Unsuccessful PCI (no antegrade

flow or 50% residual stenosis in the

IRA)

Rescue / Facilitaded PCI

Contraindication to GP IIb/IIIa

inhibitors

Methods

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

6.51.47.71.27.90.7Symptoms to balloon, (hrs±SD)6 (15.8)4 (10.8)10 (13.3) Previous PCI (%)

7 (18.4)12 (32.4)19 (25.3)Killip class III (%)1 (2.6)3 (8.1)4 (5.3)Renal Failure (%)

19 (50.0)8 (21.1)15 (39.5)015 (39.5)1631112127

24 (64.9)9 (24.3)11 (29.8)2 (5.4)12 (32.4)16510 12223

43 (57.8)17 (22.7)26 (34.7)2 (2.7)27 (36.0)1641312035

Risk factors Hypertension (%) Diabetes (%) Smoking (%) Obesity (%) Family History of CAD (%) Cholesterol (mg/dl±SD) Triglycerides (mg/dl±SD)

23 (60.5)24 (64.7)47 (62.7)Males (%)

67.414.165.813.1 66.310.6Age, yrs±SD

Thrombectomy Group (n=38)

Conventional Group (n=37)

Total Population

(n=75)

LVEF (%±SD) 43.1 ±12 41.9 ±0.940.8 ±7.5

CLINICAL CHARACTERISTICS

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

PROCEDURAL CHARACTERISTICS 1

0.70.3MLD pre, mm±SD 0.80.4 0.90.4

Total Population

(n=75)

ThrombectomyGroup (n=38)3 (7.9)

14.94.9

2.90.6

ConventionalGroup (n=37)

 IABP (%) 7 (9.3) 4 (10.8)

Lesion length, mm±SD 13.85.7 14.15.6

Vessel size, mm±SD 2.90.6 2.80.5

GPIIb/IIIa Inhibhitors

Direct stenting

Post-dilatation

Post-PCI diameter stenosis, (%±SD)

Stent Type (%) Bare-metal Stent Drug-eluting Stent

75 (100) 37 (100) 38 (100)

32 (42.6) 

2 (5.4)*§

3 (8.1)

 

28 (74.3)§

4 (10.5)

2.90.7

7 (9.3)

2.80.5 2.90.3MLD post, mm±SD

3.45.2 3.53.9 3.45.4

 29 (38.7)46 (61.3)

 17 (45.9)20 (54.0)

  12 (31.5) 26 (68.4)

* 2 pts with recanalized IRA after guide-wire placement § p= <.0001

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

PROCEDURAL RESULTS 1

0102030405060708090

100

Basal Post POBA Final Basal Post-Thromb

Final

TIMI 0/1 TIMI 2 TIMI 3

TIMI FLOW GRADE

CONVENTIONAL GROUP THROMBECTOMY GROUP

p=nsp=0.0005

%

97.8

45.9

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

MYOCARDIAL BLUSH GRADE

0

10

20

30

40

50

60

70

80

90

100

Basal Final Basal Post-Thr. Final

MBG 3

MBG 2

MBG 0/1

THROMBECTOMY GROUP CONVENTIONAL GROUP

%

*p=<0.0001

Post- POBA

32.4*

76.3*

PROCEDURAL RESULTS 2

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

90’ ST resolution after PCI( > 70% decrease of ST segment)

THROMBECTOMY

GROUP

CONVENTIONAL

GROUP

p=.0001

0

%

84.2

10

20

30

40

50

60

70

80

90

100

40.5

OR 7.2 (95% CI 2.5-20.9)

In-Hospital Outcome

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

MRI Results-1

3 d 3 m 3 d 3 m

0.12±0.4 * *§ §

MRI evaluation

p=.004 within the same group*§p=.004 within the same group

╪ ╪

p=.001 between the groups╪

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

gg

0

2

4

6

8

10

12

14

16

18

20

Hypo 3 Days Hypo 3 Months Hyper 3 days Hyper 3 Months

Standard PCI

Thrombectomy

gr

MRI Results-2

p=0.004

P<0.001

p=0.004

Hypo 3 Days Hypo 3 Months Hyper 3 Days Hyper 3 Months

4.04 0.122.7

17.39

11.01

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

In this study Thrombectomy has been demonstrated to be safe and effective in AMI setting during Primary PCI.

Compared with conventional stenting, in patients with intracoronary visible and occlusive thrombus, pretreatment with manual aspiration thrombectomy during primary PCI improves acutely the parameters of myocardial tissue perfusion and ST resolution in a well selected population.

MRI long term evaluation showed a reduction of microvascular damage in the Thrombectomy group compared with the Control group.

In the Thrombectomy group setting resulted a reduction of microvascular damage and infarct size in long term compared with acute evaluation.

Conclusion

Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I

Thank You !